OXY MAXIMUM STRENGTH ACNE CREAM CLEANSER cream

Oxy Maximum Strength Acne Cream Cleanser by

Drug Labeling and Warnings

Oxy Maximum Strength Acne Cream Cleanser by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne treatment

Uses

• for the treatment of acne
• clears acne pimples and allows skin to heal
• penetrates pores to control blackheads and whiteheads
• helps prevent new acne pimples from forming

WARNINGS

For external use only

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips, and mouth
• avoid contact with hair and dyed fabrics, which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

irritation becomes severe

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet face
• apply to hands then massage gently into face. If desired, leave on for 1-2 minutes.
• rinse thoroughly and pat dry
• follow with a non-comedogenic moisturizer if needed
• because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times

daily if needed or as directed by a doctor

• if bothersome dryness or peeling occurs, reduce application to once a day or every other day
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products

and ask a doctor.

Other information

• THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
• KEEP TIGHTLY CLOSED
• avoid storing at temperatures above 100°F (38°C)

Inactive ingredients

water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, chlorphenesin, citric acid, fragrance, glycerin, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, PEG-8 dimethicone, pentylene glycol, phenoxyethanol, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

Questions?

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

OXY MAXIMUM STRENGTH ACNE CREAM CLEANSER 
oxy maximum strength acne cream cleanser cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-1003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FRAGRANCE 13576 (UNII: 5EM498GW35)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE)
CITRIC ACID (UNII: 2968PHW8QP)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
RHODOMYRTUS TOMENTOSA FRUIT (UNII: Q99511S58K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-1003-1	148 mL in 1 TUBE; Type 0: Not a Combination Product	08/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/15/2024

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	manufacture(10742-1003)